ADDITIVE FORMULA 3- dextrose monohydrate, trisodium citrate dihydrate, sodium chloride, sodium phosphate, monobasic, monohydrate

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

Dextrose Monohydrate (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK), Trisodium Citrate Dihydrate (UNII: B22547B95K) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL), Sodium Chloride (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698, SODIUM CATION - UNII:LYR4M0NH37), SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37), Citric Acid Monohydrate (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL), Adenine (UNII: JAC85A

Commercializzato da:

Terumo BCT, Ltd

Via di somministrazione:

INTRAVENOUS

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Use only with Trima Accel red blood cell (RBC) apheresis collections. [See Dosage and Administration (2).] DO NOT INFUSE ADDITIVE SOLUTION FORMULA 3 (AS-3) DIRECTLY TO THE DONOR. ADDITIVE SOLUTION FORMULA 3 (AS-3) has not been studied in controlled clinical trials with specific populations.

Dettagli prodotto:

ADDITIVE SOLUTION FORMULA 3 (AS-3) is a clear solution supplied in sterile and non-pyrogenic Polyolefin bags. STORAGE Up to 25 °C. Protect from freezing.

Stato dell'autorizzazione:

New Drug Application

Scheda tecnica

ADDITIVE FORMULA 3- DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE,
SODIUM CHLORIDE,
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND
ADENINE SOLUTION
TERUMO BCT, LTD
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ADDITIVE SOLUTION FORMULA 3 (AS-3)
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ADDITIVE
SOLUTION FORMULA 3 (AS-3).
ADDITIVE SOLUTION FORMULA 3 (AS-3)
STERILE FLUID
POLYOLEFIN BAG
INITIAL U.S. APPROVAL: 2002
INDICATIONS AND USAGE
Use only with Trima Accel red blood cell (RBC) apheresis collections.
(1)
DOSAGE AND ADMINISTRATION
AS-3 is added to tubing sets after apheresis collections, after the
donor has been disconnected. (2)
AS-3 may only be used with the Trima Accel apheresis device. For
instructions on the use of the solution see the
device operator's manual. (2.1)
Follow the directions for connecting the AS-3 bag to the tubing set of
a blood collection system. (2.2)
DOSAGE FORMS AND STRENGTHS
100 mL, 200 mL, or 350 mL sterile fluid in a Polyolefin bag. (3)
CONTRAINDICATIONS
DO NOT INFUSE AS-3 DIRECTLY TO THE DONOR. (4)
WARNINGS AND PRECAUTIONS
Verify that the AS-3 bag has been securely attached to the system
tubing set. Use aseptic technique throughout all
procedures to ensure product quality. (5)
Do not reuse. Discard unused or partially used solution bags.
ADVERSE REACTIONS
Citrate reactions or toxicity may occur with the infusion of blood
containing citrate. The recipient of the blood containing
citrate should be monitored for the signs and symptoms of citrate
toxicity. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TERUMO BCT, INC. AT
1-877-339-4228 OR FDA AT 1-800-
FDA-1088 OR _WWW.FDA.GOV/MEDWATCH_.
REVISED: 7/2018
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 General Dosing Information
2.2 Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
6 ADVERSE REACTIONS
8 USE IN SPECIFIC POPULATIONS
11